Beraprost therapy for pulmonary arterial hypertension
| Autor: | Robyn J, Barst, Michael, McGoon, Vallerie, McLaughlin, Victor, Tapson, Stuart, Rich, Lewis, Rubin, Karlman, Wasserman, Ronald, Oudiz, Shelley, Shapiro, Ivan M, Robbins, Richard, Channick, David, Badesch, Barry K, Rayburn, Robin, Flinchbaugh, Jeff, Sigman, Carl, Arneson, Roger, Jeffs |
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| Jazyk: | angličtina |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Hypertension Pulmonary Vasodilator Agents Hemodynamics Administration Oral Prostacyclin Selexipag Severity of Illness Index Drug Administration Schedule law.invention chemistry.chemical_compound Randomized controlled trial Double-Blind Method law Internal medicine medicine Humans Exercise Tolerance Dose-Response Relationship Drug business.industry Respiratory disease medicine.disease Pulmonary hypertension Epoprostenol Surgery Beraprost Clinical trial chemistry Cardiology Quality of Life Female business Cardiology and Cardiovascular Medicine medicine.drug Follow-Up Studies Tablets |
| Zdroj: | Journal of the American College of Cardiology. (12):2119-2125 |
| ISSN: | 0735-1097 |
| DOI: | 10.1016/S0735-1097(03)00463-7 |
| Popis: | ObjectivesThe purpose of this study was to assess the safety and efficacy of the oral prostacyclin analogue beraprost sodium during a 12-month double-blind, randomized, placebo-controlled trial in patients with pulmonary arterial hypertension (PAH).BackgroundPulmonary arterial hypertension is a progressive disease that ultimately causes right heart failure and death. Despite the risks from its delivery system, continuous intravenous epoprostenol remains the most efficacious treatment currently available.MethodsA total of 116 patients with World Health Organization (WHO) functional class II or III primary pulmonary hypertension or PAH related to either collagen vascular diseases or congenital systemic to pulmonary shunts were enrolled. Patients were randomized to receive the maximal tolerated dose of beraprost sodium (median dose 120 μg four times a day) or placebo for 12 months. The primary end point was disease progression; i.e., death, transplantation, epoprostenol rescue, or >25% decrease in peak oxygen consumption (VO2). Secondary end points included exercise capacity assessed by 6-min walk test and peak VO2, Borg dyspnea score, hemodynamics, symptoms of PAH, and quality of life.ResultsPatients treated with beraprost exhibited less evidence of disease progression at six months (p = 0.002), but this effect was not evident at either shorter or longer follow-up intervals. Similarly, beraprost-treated patients had improved 6-min walk distance at 3 months by 22 m from baseline and at 6 months by 31 m (p = 0.010 and 0.016, respectively) compared with placebo, but not at either 9 or 12 months. Drug-related adverse events were common and were related to the disease and/or expected prostacyclin adverse events.ConclusionsThese data suggest that beneficial effects may occur during early phases of treatment with beraprost in WHO functional class II or III patients but that this effect attenuates with time. |
| Databáze: | OpenAIRE |
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